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PROLINE TruLab N - Indonesia BPOM Medical Device Registration

PROLINE TruLab N is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 20101520227. The device is manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH from Germany, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is PT. PRODIA MEDICAL DISTRIBUTION.

This page provides comprehensive regulatory information including complete registration details, manufacturer information, authorized representative details, product classification, and related products. Pure Global AI offers free access to 67,600+ Indonesia medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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BPOM Registered
Risk Class Kelas Resiko : B
PROLINE TruLab N
Analysis ID: AKL 20101520227

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Country of Origin

Germany

Authorized Representative

PT. PRODIA MEDICAL DISTRIBUTION

AR Address

Grha Prodia Utama Lantai 3 Unit 3 C, Jl. Raden Saleh No. 53

Registration Date

Feb 01, 2025

Expiry Date

Jan 30, 2028

Product Type

Clinical Chemistry Test System

Quality control material (assayed and unassayed) (cair)

Invitro Diagnostics

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